Clinical trial

Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions

Name

1609017561

Description

Unblinded, controlled, non-randomized, mechanistic study to determine whether physiological mechanisms underlying PVC are sensitive to adenosine. One hundred subjects undergoing clinically-indicated, standard-of-care cardiac electrophysiology study (EPS) procedure for PVCs will receive adenosine and/or verapamil to learn if their arrhythmias are inducible similarly to sustained ventricular tachycardia.

Trial arms

Trial start

2017-02-13

Estimated PCD

2025-06-30

Trial end

2025-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Adenosine

Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg

Arms:

Adenosine/ Verapamil Arm

Other names:

Verapamil 0.15 mg/kg

Size

100

Primary endpoint

Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;

baseline

Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs.

baseline

Eligibility criteria

Inclusion Criteria: * Diagnosis of premature ventricular contractions (PVCs) * Scheduled to undergo an electrophysiology study with the intention of performing cardiac ablation for the treatment of PVCs * Male or female between the ages of 18 and 70 years * Capable of giving informed consent Exclusion Criteria: * Any structural heart disease * Coronary artery disease (≥ 70% stenosis) * Current treatment with anti-arrhythmic drugs * Pregnant * Asthma (if administering adenosine)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-09-26

1 organization

1 product

1 indication

Organization

Weill Medical College of Cornell University

Product

Adenosine

Indication

Premature Ventricular Contraction